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Page 1: Medical Devices in India - AdvaMed · 1 Medical devices in India- an agenda to effective healthcare delivery Contents of this report are based on a study commissioned by AdvaMed and

Medical devices in India - an agenda to effective healthcare delivery

Page 2: Medical Devices in India - AdvaMed · 1 Medical devices in India- an agenda to effective healthcare delivery Contents of this report are based on a study commissioned by AdvaMed and

1 Medical devices in India- an agenda to effective

healthcare delivery

Contents of this report are based on a study commissioned by AdvaMed and conducted by IQVIA on

behalf of AdvaMed.

IQVIA’s Services (in conducting the above-mentioned study) are provided on an “as is” basis without

any further warranties of any kind. IQVIA does not warrant that the Services shall meet the present or

future needs or objectives of AdvaMed and AdvaMed assumes sole responsibility for the use, selection,

and suitability of the Services to its needs and objectives. In addition, IQVIA shall not be liable for any

expressions of opinion, evaluations or forecasts contained within the Services. Where the Services are

based on information provided by AdvaMed or a third party, IQVIA shall be entitled to assume that such

information is accurate. Furthermore, AdvaMed warrants that it has full rights to supply to IQVIA any

electronic file, database, data and/or other information transferred to IQVIA in connection with the

performance of the Services.

To the fullest extent permitted by law, IQVIA does not accept or assume responsibility to any person

other than AdvaMed for any matter contained in or referred to in the Services or for any reliance placed

on the information contained in the Services by any person other than AdvaMed.

Disclaimer

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2 Medical devices in India- an agenda to effective

healthcare delivery

Table of Contents

1. Foreword

2. Introduction

3. Challenges to access to advanced medical devices

• Low awareness of disease

• Shortage of infrastructure and trained manpower

• Inadequate health insurance coverage coupled with poor reimbursement

limits are impacting access to affordable care

• Significant other costs drive affordability of procedures involving medical

devices

4. Case Study - Impact of Stent Price Control

5. Recommendations

• Build medical infrastructure closer to the patient base

• Procure medical devices under public health schemes to increase

accessibility and improve affordability

• Increase availability of trained talent to better diagnose disease and provide

necessary treatment

• Culture of preventive healthcare through greater spending on healthcare,

especially primary care

• Usher reforms in insurance sector for better health insurance coverage &

establish systems to rationally decide reimbursement price

• Adopt alternate models to increase affordability of medical devices

• Establish a holistic ecosystem for medical device industry

6. Conclusion

7. Industry views

04

06

10

12

14

17

19

20

24

25

26

27

28

29

32

33

34

35

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3 Medical devices in India- an agenda to effective

healthcare delivery

AF Atrial fibrillation

APHRS Asia Pacific Heart Rhythm society

AV Atrioventricular

AYUSH Deptt. Of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy

BMS Bare Metal Stent

CHC Community Health Care

CRT Cardiac Resynchronization Therapy

DES Drug Eluting Stent

ECG Electrocardiograph

ELR External Loop Recorder

EP Electrophysiologist

GAS Group A Streptococcal

GDP Gross Domestic Product

ICD Implantable Cardioverter Defibrillator

ICTPH IKP Center for Technologies in Public Health

HTA Health Technology Assessment

OA Osteoarthritis

PT Prothrombin Time

RA Rheumatoid Arthritis

RHD Rheumatic Heart Disease

SSS Sick Sinus Syndrome

URTI Upper Respiratory Tract Infection

Glossary

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4 Medical devices in India- an agenda to effective

healthcare delivery

The fundamental purpose of the life sciences industry is allow people to live longer, healthier, more

productive and independent lives. These efforts include developing and ensuring access to quality

medical devices and diagnostics, to help provide the best possible care for patients. With the ever-

increasing disease burden in India, and non-communicable diseases (NCDs) on the rise, it’s clear that

an important part of the solution to these health care challenges will be adoption of innovative medical

technologies.

The global medical technology industry provides safe and effective products that save and improve

lives, while also yielding savings across the health care system by replacing more invasive procedures,

reducing hospital stays and allowing people to return to work more quickly. At the same time, MedTech

companies in India – and multinationals that have established a significant presence in the country –

provide high quality jobs in communities both large and small, and help support training of health care

professionals on use of life-changing innovations. To advance these benefits of medical technology, it’s

essential to have the right public policies in place, including a predictable regulatory environment, to

support continued investment, innovation and patient access.

The Government of India has put health care front and center with a bold set of policy and regulatory

activities that have made great strides for the benefit of patients. Measures to expand access to safe

and effective medical products include the recent introduction of globally harmonized rules and

classification for medical devices, and establishing a Medical Technical Advisory Board. Meanwhile,

some measures like price controls have not translated into improved access and affordability for

patients.

It is clear that effective policy solutions to health care challenges in India and elsewhere must take a

holistic approach, including a focus on the value of care, to help achieve cost optimization at various

levels. The Advanced Medical Technology Association (AdvaMed), the world’s largest medical

technology trade association, recently commissioned a study which was conducted by health care data

science firm, IQVIA, on behalf of AdvaMed, to understand the key challenges impacting access to

medical technology in the country. Besides other broader areas the study focuses on, findings from the

study hint that capping MRPs on medical devices has not resulted in significantly lower overall cost of

procedure to patients. This, and other insights on factors limiting access to procedures, are elucidated in

this paper.

Alternatives to mechanisms such as price control should be explored, that facilitate differential pricing

for innovative medical technologies. This will pave way for improved healthcare access in the country,

making the healthcare ecosystem stronger. What India needs at this juncture is to see the larger picture

of improved healthcare access to patients, rather than just focusing on controlling the prices of devices.

Therefore, concentrated efforts are required across the value chain to ensure that government policies

ultimately benefit patients. This will also help in achieving the government’s long-term goal of universal

health coverage.

The medical technology industry – led by AdvaMed – is eager to continue discussions with India’s

government toward effective solutions, to help the government achieve its stated health care goals and

revolutionize health care in India.

Foreword by AdvaMed

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5 Medical devices in India- an agenda to effective

healthcare delivery

With changing lifestyle and increased life expectancy, prevalence of chronic and non-communicable

diseases has increased. This has led to increased demand for medical devices, which plays an

important role throughout the healthcare ecosystem and enable people to live healthier and productive

lives.

Realizing the importance of the medical device industry, the Government of India has taken some

measures in last few years for the betterment of the sector. Initiatives include, introduction of new

Medical Device Rule, classification system for medical devices, and setting up of Medical Technical

Advisory Board to regularize the sector. Investment in med tech parks to provide impetus to local

manufacturing of medical devices which in turn may lead to decrease in cost of medical devices and

increase accessibility.

However, despite these initiatives, medical device market in India is still underpenetrated and access to

quality and affordable medical service remains a challenge.

Different stakeholders have different views on addressing issues around access and affordability e.g.

Government agencies have focused on reducing the price of devices, while other stakeholders holders

believe insufficient funding and inadequate infrastructure are the main barriers to access.

To understand the key challenges impacting access to medical technology in the country, AdvaMed has

conducted a study on the same, with the assistance of IQVIA. The study suggests that constrained

infrastructure very often plays a greater role in limiting access to procedures, than affordability. For

example, when the government brought stents under price control, the objective was to improve

affordability and accessibility to angioplasty procedures. However, initial findings on a sample base

indicate that (1) benefits to patients (2) growth in procedure volumes; and (3) average stent

consumption, per patient have not indicated significant change in the short term, while the long term

impact remains to be seen.

The study also provides recommendations on interventions on the part of policy makers to overcome

key challenges in bringing quality healthcare, and sophisticated medical devices, to a significantly wider

patient base.

Foreword by IQVIA

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6 Medical devices in India- an agenda to effective

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1 Industry reports

Indian medical device industry is bringing benefits of advanced

medical technology to patients

Industry plays an important role in providing access to advanced medical technologies. Innovation in

medical technology is enabling people to live healthier and productive lives, thus improving the overall

efficiency of healthcare system.

Factors like changing demographics, rising life expectancy, increase in healthcare facilities and rising

prevalence of lifestyle diseases have contributed to the growth of medical device industry in India.

While the medical device industry is growing fast, it is still at a very nascent stage, especially in

comparison to similar economies such as China, Brazil, Russia or USA. Per capita spend on medical

devices in India is the lowest at USD 3 as compared to USD 28 in Brazil, USD 43 in Russia and USD 304

in the USA. India’s medical device industry is underpenetrated and access to quality, affordable

healthcare still remains a constraint.

The medical device industry in India is estimated to be valued at USD 4.9 bn1 and is growing at ~17%

over last few years.

Indian medical device industry is evolving towards a well established and regulated sector from being a

primarily MNC dominated unregulated sector in 1980s.

Introduction

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7 Medical devices in India- an agenda to effective

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2 http://pib.nic.in/newsite/PrintRelease.aspx?relid=157955

Government of India has taken number of measures to strengthen the medical device sector ecosystem

in India and ensure increased access to medical devices. Some of the prominent measures taken by the

Government are highlighted next.

Government of India has taken key initiatives in recent years to create

a conducive environment for growth of medical device industry

National Health Policy (NHP) 2017

National Health Policy 2017 aims to strengthen the Healthcare ecosystem of India by addressing the

challenges of accessibility, affordability and availability of infrastructure and skilled manpower in India.

Key highlights:

• Government plans to increase healthcare spend from 1.4% to 2.5% of GDP

• The Policy puts more emphasis on preventive healthcare

• In line with the “Make in India” theme, the Policy aims to make the environment conducive for the

manufacturing of drugs and devices in India

• The Policy has enlisted quantitative targets for reducing infant mortality, under-five mortality and neo-

natal mortality rate, and aims to increase life expectancy to 70 years.

• The Policy proposes to address the infrastructure constraints of healthcare by improving the ratio,

number of beds per 1000 in population, from current 0.9 to 2. The Policy also puts emphasis on

establishing Public Private Partnership (PPP) model to address the infrastructure and human resources

constraints

• To address the challenge of affordability to the underprivileged mass segment, the Policy seeks to

provide free drugs and diagnostic services in the public hospitals

• With strong emphasis on primary healthcare, the Government plans to introduce health cards for easy

access to primary care facilities

• In line with the “Digital India” theme, the Policy proposes to establish the National Digital Health Authority

(NDHA) to deploy digital sources for measuring and improving the efficiency and outcomes of healthcare

system.

Medical Devices Rule, 20172

In order to separate medical device industry from pharmaceutical industry, the Ministry of Health and

Family Welfare of India has introduced the Medical Devices Rule, 2017. The new rule aims to change

the way medical devices are currently regulated in India. Under the new rule, medical devices will be

classified, based on risk associated with them, into four classes:

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Until now, there was no medical device specific clinical trial guidelines or framework in India. Under the new

rules, the Government has made separate provisions to bring in more transparency and regulation in

clinical trials of medical devices.

Currently, registration of a foreign manufacturer requires an import license as well as registration certificate

for the foreign manufacturer, its site and products. Under the new rule, registration is no longer required;

however, foreign manufacturers still need to apply for the import license. Further, Government has also put

an end to the periodic renewal of licenses. To expedite approval, the entire process has been made online.

National Medical Device Policy- 20153

To strengthen the medical device sector in India, reduce import dependence and set up a strong base of

medical devices, the Government of India has drafted the National Medical Device Policy, 2015. Salient

features of the Policy are described below:

• Setting up an autonomous body “National Medical Device Authority (NMDA)” to serve as the central

agency for the medical device industry

• Policy outlines several financial and taxation benefits such as weighted tax deductions on R&D

expenditure, low cost funding like interest subsidy to small-medium-enterprises (MSME), providing seed

capital to med-tech start-ups etc.

• Minimum or zero import duty on the import of raw materials and manufacturing equipment for production

of medical devices

• Setting up skill development committee under NMDA to identify skill gap and addressing this

Medical Technical Advisory Board (MTAB)4

The Government of India is in the process of setting up a Medical Technology Assessment Board (MTAB)

under the Department of Health Research (DHR) in the Ministry of Health & Family Welfare. Key objectives

of the Board are:

• Encourage and standardize cost effective health interventions to reduce cost

• Reduce overall out of pocket expenditure in medical treatment.

• Streamline the medical reimbursement procedures

In support of this effort, International Decision Support Initiative (iDSI) has received a supplementary grant

from the Bill and Melinda Gates Foundation (BMGF) to support the institutionalization of HTA in India.

Severity of Risk Classification

Low risk Class A

Low moderate risk Class B

Moderate risk Class C

High risk Class D

3http://pharmaceuticals.gov.in/sites/default/files/Draft%20National%20Medical%20Dev

ice%20Policy%20-%202015.pdf 4http://www.globalhitap.net/newsandevents/establishment-of-the-medical-technology-

assessment-board-mtab-initiating-health-technology-assessment-hta-in-india/

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Local manufacturing & encouraging innovation

To give a boost to “Make in India” campaign, and to encourage local manufacturing, Government

announced setting up three medical tech parks3 in Andhra Pradesh, Maharashtra and Gujarat. These parks

will have in-house specialised testing facilities, and manufacturing units.

Further Government plans to setup/ promote incubation centres through appropriate incentive structure/

cost sharing to address capabilities gap in R&D infrastructure, testing quality or calibration etc. For

example, Biotechnology industry Research Assistance Council (BIRAC), through its flagship schemes, has

supported 100+ entrepreneurial ventures in medical technologies.

These parks and incubators are expected to provide impetus to local manufacturing of medical devices,

which in turn may lead to decrease in cost of medical devices and increase accessibility.

Price control

The medical device industry has been under the scanner of various Government agencies, focusing on

reducing the price of devices with an aim to make healthcare more affordable and accessible. In a move to

meet this objective, National Pharmaceutical Pricing Authority (NPPA) slashed the prices of coronary stents

and knee implants as much as 85% and 69%, respectively5.

This move has led to several concerns for the medical device industry, highlighting the need for establishing

right framework to identify key parameters impacting access to devices in India.

Impact of stent price control is highlighted on Pg. 20-23 of the report

5https://economictimes.indiatimes.com/industry/healthcare/biotech/

pharmaceuticals/fearing-more-price-control-medical-cos-propose-

govt-to-voluntarily-cut-prices/articleshow/60330951.cms

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Effective, appropriate and sustainable delivery of quality healthcare

with advanced medical devices depend on the 3As of awareness,

availability and affordability

Awareness

Affordability

Knowledge of disease and

its symptoms among

patients and physicians for

timely and optimal

diagnosis

Availability of hard

infrastructure (hospitals),

screening tools and trained

manpower at places close

to disease origin

Universal health insurance

coverage with adequate

reimbursement programs

and effective procedure

pricing

For a large number of Indians today, health systems’ goal of accessible, affordable and quality

healthcare remain inadequate due to multiple challenges across the above parameters.

Challenges to access to advanced medical devices

Availability

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11 Medical devices in India- an agenda to effective

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Challenges exist across the care pathway impacting effective

healthcare delivery in India

Incidence DiagnosisTreatment / Follow

up

Low awareness of disease risk

factors among patients

Limited focus on preventive

care & tendency to ignore

symptoms

Absence of Government

sponsored screening programs

Lack of awareness of disease

symptoms among physicians

Lack of availability of screening

tools like X-ray, ELR, ILR,

ECG, CT scan etc.

Lack of training of primary

physicians to interpret medical

reports

Awareness Availability Affordability

Lack of guidelines for disease

symptom specific treatment

Inadequate healthcare

infrastructure in low tier towns

Low number of trained

manpower like cardiac

surgeons, EPs in India

Low penetration of healthcare insurance

Poor reimbursement limit of existing insurance programs

Absence of robust pricing model linking price to clinical outcomes

Quality

Lack of defined framework for categorization of various categories of devices

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Awareness amongst the Indian public on disease symptoms and its management has never been stellar.

Multiple studies have highlighted the low awareness of disease symptoms related to cardiovascular

disease, diabetes etc. among the Indian population. As per these studies, ~40-50% of the Indian

population is unaware of the risk factors related to cardiovascular diseases and hypertension6.

Low awareness of cardiovascular disease symptoms in India leading to significant attrition of patients

across the care pathway is evident in case of rheumatic heart disease (RHD), where ~3-3.5 mn7 patients

suffer from the disease, however, only ~42,000 patients get the required valve surgery treatment

Likewise there are ~180 mn8 arthritis patients in India, but low awareness and delayed diagnosis, due to

late referral by general physician to specialist, is leading to significant attrition of patients across care

pathway

6 http://www.ijopp.org/sites/default/files/IJOPP_7_2_2014_5.pdf,

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3342579/7 pib.nic.in/newsite/PrintRelease.aspx?relid=128227 8http://www.arthritis-india.com/

Low awareness of disease and its symptoms is leading to

significant attrition of patients across the care pathway3.1

Note- Infographics are for the purpose of illustration. Exact incidence of Arthritis patients not available

Attrition of patients across care pathway for Arthritis8

In our country, patients usually lack awareness of disease

and its symptoms, which leads to delay in diagnosis and

treatment… contributing to significant joint deformities

Senior Orthopedician, New Delhi

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13 Medical devices in India- an agenda to effective

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Challenges at both the patient and physician level are leading to low no. of

patients opting for treatment and sub-optimal diagnosis

• Low awareness of disease symptoms among the population

• Tendency to ignore symptoms due to lack of knowledge

• Lack of Government sponsored screening programs

• Patients opting for alternative systems of medicine to avoid surgery,

usually seen in case of arthritis patients

Patient Challenges

Patients opt for lifestyle changes or dietary modifications

to hold the disease condition at abeyance rather than

prescribing to drug or device treatment leading to

worsening of disease over time

Consulting physician, Haridwar

• Low awareness of disease symptoms among general physicians

• Lack of India specific protocols highlighting treatment pathway based

on disease symptoms

• Delayed diagnosis due to late referral by general physicians to

specialists like Cardiologist and Orthopedician

• Lack of trained physicians who could interpret medical reports like

ECG, X-ray, MRI, CT scan reports, etc.

• Poor availability of long term monitoring devices like external loop

recorders, Holter and internal loop recorder

Physician Challenges

Initiatives vis-à-vis affordability and accessibility will not bear fruit till awareness

problem is solved

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14 Medical devices in India- an agenda to effective

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Healthcare penetration in India9

7%

33%42% 34% 40%

8%

22%

26% 36% 43%85%

45%32% 20%

17%

Population No. ofhospitals

No. of beds Cath labs Operatingrooms

Metro

Tier 1

Others

Further, prevalence of disease is higher in low tier cities10 as compared to metro cities as seen in the

case of rheumatic heart disease (RHD) while key infrastructure for RHD treatment, i.e. operating rooms

are skewed towards metro cities

0.3

1.2 1.1

0.9

0.6

0.3

0.1

1.0

0.1 0.1

Metro I Tier II Tier III

More than 80% of the Indian population resides in low tier towns however, the infrastructure to provide

healthcare services is skewed towards Metro cities.

9 Population census, data shared by steering committee members10 Jai Vigyan Mission mode project, ICMR report

India faces a severe shortage of both hard infrastructure and

trained manpower closer to disease origin

Majority of patients needing treatment are from places other than where the

treatment center is located, thus limiting access

3.2

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15 Medical devices in India- an agenda to effective

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Even in case of cardiac stents where Government slashed prices to increase access, the primary

objective was not achieved due to absence of required infrastructure.

(Details on the Impact of Stent Price Control on Pg. 20-23 of the report)

Our hospital has thousands of patients from within and

outside the city. Our Cath lab is overbooked and there is a

waiting period of 2-3 weeks for elective procedures…

Hospital Administrator, Tertiary Hospital

12 APHRS Whitebook 2015

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16 Medical devices in India- an agenda to effective

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There is a dearth of trained physicians vis-à-vis the high patient population in India. The current number

of qualified Cardiothoracic surgeons (900-110011) and cardiologists are not sufficient to meet the rising

demand for treatment. The key reasons for low number could be attributed to:

Low number of medical seats for these specialties e.g. only ~100 seats for Cardiothoracic

surgeons14 and many of these seats remain vacant

Lack of structured course for electrophysiology/pacing therapy in the DM/DNB curriculum

Absence of Government sponsored training programs for doctors

Further, specialist doctors are mostly located in metro cities while majority of population requiring

treatment are located in low tier towns.

Spread of surgeons in India12

7%

55% 57%

76%

8%

35%37%

10%

85%

10% 6%14%

Population Cardiacsurgeons

Cardiologists Orthopedicsurgeons

Metro

Tier 1

Others

11 Vaithianathan R, Panneerselvam S. Emerging alternative model for

cardiothoracic surgery training in India.12 Data shared by steering committee members

Low availability of trained manpower further restricts the access to

medical devices in India

“Poor accessibility severely curtails the ability of medical devices to

percolate in low tier cities”

In the case of drugs, ensuring availability through efficient supply chain could increase access.

However, for medical devices, presence of required infrastructure is critical to ensure access.

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As per the Economic Survey 2015-2016, Government (Central and state governments combined)

expenditure on health as percentage of GDP was only ~1.3 per cent. This is much lower than other

developing and developed nations.

Low GDP spend on healthcare is evident in low penetration of health insurance in India, with only ~37%

of population covered by some form of insurance. Further, the reimbursement limits and coverage by

these Government sponsored insurance programs are not sufficient to meet the entire therapy cost.

8.3 8.57.5

6.3

3.8 3.11.4

USA Japan United Kingdom Australia Brazil China India

% of GDP spent on health expenditure13

13 World Health Organization Global Health Expenditure database14 https://www.jeevandayee.gov.in/

http://www.aarogyasri.telangana.gov.in/web/guest

http://www.cmchistn.com/

Inadequate health insurance coverage coupled with poor

reimbursement limits are impacting access to affordable care3.3

Key challenges with the Government sponsored programs when compared

with private programs are:

1. Low reimbursement limit

Reimbursement limits in pacemaker schemes varies from INR 75000-1,50,000, while a typical

pacemaker surgery costs greater than INR 2,00,00018. Similarly, reimbursement limits in valve

surgery varies from ~1,20,000 – 2,00,000 while typical valve surgery cost varies from 2,50,000 to

5,00,00015. Low reimbursement limit is leading to mismatch between therapy required and therapy

used

2. Non coverage of all device variants

Government sponsored schemes do not cover different types of devices. In case of cardiac stents,

state government schemes like Bhamashah Yojana (Rajasthan) and Mukhyamantri Amrutum

Yojana (Gujarat) covered only Bare Metal Stent till earlier. Only recently, coverage is extended

towards Drug-Eluting Stents (DES) as well.

Due to non coverage of DES earlier in Government schemes, patients could not receive newer

generation stents which are proven to be more effective in long run.

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15 Primary interactions with cardiologists and hospital administrators

3. Low post surgery coverage

There is minimal post treatment coverage in these reimbursement schemes, whereas most of these

procedures involve post treatment cost, e.g. in case of Angioplasty, patients require regular

monitoring with ECG, tests like Blood sugar, Lipid Profile, Renal function test and annually Echo

cardiogram which is an added cost to the patient. Similarly, in the case of knee implants,

physiotherapy treatment is required in no. of patients post surgery.

In the absence of post surgery coverage, patient tend to avoid these costs leading to increased

mortality and morbidity in case of valves, while impacting patients quality of life in case of knee

implants.

4. Lack of coverage of key surgical procedures

Some of the Government sponsored schemes do not cover key surgical procedures such as joint

replacement procedures. E.g. Aarogyasri and Dr. N.T.R Seva Schemes do not reimburse patients

for knee and hip replacement surgery. Due to non coverage of these procedures, patients who are

in need of these surgeries either remain undertreated or usually opt for alternate forms of treatment.

This leads to worsening of patients disease state.

Further low reimbursement limit restricts the ability of hospitals to select premium quality knee or

hip implants, with significant evidence and international approvals, as per patient etiology.

Since joint replacement surgeries are not covered in

schemes, patients who need these surgeries returns back

untreated

Orthopedician, Andhra Pradesh

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There are 5 key components contributing to the overall procedure cost at a hospital:

There has been an increased focus of Government to reduce the price of devices to increase

accessibility to procedure, however, it has been observed that device cost is only 30-40% of the overall

procedure cost, while other components of the procedure are contributing to the remaining 60-70% cost.

Other costs of the procedure are mainly driven by doctor fees which is decided by the hospitals based on

complexity of the procedure performed by the doctor and doctor’s experience. Costs also vary with the

location of the hospital (urban/ rural), hospital infrastructure and complexity of the procedure conducted.

Hip

replacement

30-32%

68-70%

Knee

replacement

32-36%

64-68%

Angioplasty*

38-40%

60-62%

Implant cost

Includes doctor

fees, room rent,

cost of medicines,

diagnostic and

other charges

Breakup of procedure cost across components16

16 Primary interactions with Cardiologists, Orthopedicians, Cardiothoracic

surgeons, Hospital administrators and patients17 Data from AdvaMed steering committee members

Significant other costs drive affordability of procedures involving

medical devices

Further, cost of implants in India is already lower compared to other geographies. For e.g. In case of

knee implants, cost of implant in India is three to four times lower than that of other countries such as

UK, USA and Canada etc.

3.4

Other Costs

Orthopedic implants prices in India vis-à-vis other geographies17

0.00.51.01.52.02.53.03.54.0

1 Device/ Implant cost 2 Doctor fees 3 Room rent

4 Drugs & Consumables 5 Diagnostic charges, hospital charges etc.

*Cost prior to stent price control

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In Summary:

• Low awareness of disease & its symptoms amongst patients and primary physicians is leading to

significant attrition of patients across care pathway

• Initiatives to improve affordability and accessibility are contingent on progress in first improving

awareness

• There is inequitable distribution of healthcare infrastructure between large cities, where healthcare

facilities are located, and smaller towns and rural, where the bulk of patients reside

• Unlike pharmaceuticals, healthcare infrastructure is critical for medical devices; poor accessibility

severely curtails penetration of medical devices to low tier cities

• Lack of insurance coverage and low reimbursement limits are impacting access to affordable quality

healthcare

• Devices are a small component of the procedure cost and focusing on cost of device alone will not

result in affordable care

• Constraining categorization and treating different types of devices under similar category will dis-

incentivize introduction of advanced technology in India

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Case Study - Impact of Stent Price Control

Background

In February, 2017, National pharmaceutical pricing authority (NPPA) slashed prices of coronary stents

by up to 80 percent. NPPA’s decision followed the Health Ministry’s 2016 notification to cover coronary

stents in the National list of essential medicines (NLEM).

The move was aimed at increasing affordability to angioplasty procedure, with expected increase in the

number of angioplasties performed.

AdvaMed Study

Objective

AdvaMed commissioned a study, which was conducted by IQVIA on behalf of AdvaMed, to understand

the impact of stent price control on the overall angioplasty procedure cost and the total number of

angioplasties performed across hospital segments.

Methodology

Study findings are based on survey and feedback of interventional cardiologists, hospital administrators

and angioplasty patients (pre and post stent price control) across hospital segments (corporate chains,

large private hospitals, mid-sized private hospitals and government hospitals) in metro and tier 1 towns.

Further, interactions were conducted with sales / marketing personnel of stent manufacturers and private

payers to validate the findings of the study.

Outcome

The initial findings from the study indicate that benefits to patients and growth in procedure volumes

have not indicated significant change in the short term, while the long term impact remains to be seen.

Corporate

chains

Large Private

hospitals

Medium Private

hospital

Government

HospitalsTotal

Interventional

Cardiologists10 14 10 10 44

Hospital

administrators7 9 8 4 28

Angioplasty

patients62 76 49 17 204

Total 79 99 67 31 276

Stakeholder

Hospital

SegmentN=10 N=14 N=11 N=10

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healthcare delivery

It is observed that reduction in stent price resulted in ~8-18% reduction in overall angioplasty procedure

cost for patients undergoing single vessel procedure (~70% of the total angioplasty patients).

Pre stent

price control

2.10 - 2.50

-8-12%

Post stent

price control

2.05- 2.20 -14-18%

Post stent

price control

1.60- 1.80

Pre stent

price control

1.90 - 2.10

-8-12%

Post stent

price control

1.15- 1.25

Pre stent

price control

1.30 – 1.40

Corporate chains Large private hospital Medium private hospital

Patients at government funded hospitals have also not

benefited significantly from stent price control as, stents

were available at less than INR 30,000, even before price

capping at majority of these hospitals.

(In some govt. hospitals/ schemes like Delhi state govt.

hospitals, Chief Minister/s comprehensive health insurance

scheme, Tamil Nadu etc. price of stent was low at ~25,000

even before price control)

0.24 – 0.63

Post stent

price control

5-20%

0.25 – 0.72

Pre stent

price control

Government hospital

Value is INR lakh

Value is INR lakh

Reduction in angioplasty cost across hospital segments

N=10 N=14 N=11

% o

f ho

sp

itals

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23 Medical devices in India- an agenda to effective

healthcare delivery

Further, there is no significant change in the growth trend of angioplasties across hospitals segments

post stent price control and angioplasties continue to grow at historical rate.

Post stent

price control

2-3%

Pre stent

price control

113 - 124110 - 120

4-5%

Post stent

price control

105 - 115

Pre stent

price control

100 - 1106-7%

Post stent

price control

65 - 75

Pre stent

price control

60 - 70

Corporate chains Large private hospital Medium private hospital

Growth driven

by hospitals in

Tier I cities

Pricing is not a constraint for patients undergoing

angioplasty at our facility… patients in need of this procedure

were getting treated earlier and the same is true at present

Interventional Cardiologist, Delhi

No.

of

Angio

pla

stie

s

80%

20%

Hospitals with no change in # of angioplasties

Hospitals with slight increase in # of angioplasties

Amongst Government hospitals surveyed, ~80%

hospitals cited no significant increase in the number of

angioplasty procedures performed, and even in the

remaining 20%, the increase was marginal (2-5% only).

Lack of adequate infrastructure was cited as the key

concern impacting access to cardiac related procedures:

• Inadequate number of cath labs across Government

hospitals to meet the demand

• Low availability of skilled interventional cardiologists to

perform the procedure

“..Cardiac specialty has limited number of post-graduate

seats, and of these only handful of Cardiologist will perform

intervention….we are always overworked and patients have

to wait for weeks for getting cardiac procedures performed at

our facility..”

Interventional Cardiologist

Findings from the study highlights that singular focus on controlling prices of devices without attempting

to address the large picture will not improve patient access. An enhanced access to quality care requires

a holistic approach encompassing cost optimization at various levels in healthcare delivery and

investments to strengthen healthcare infrastructure.

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24 Medical devices in India- an agenda to effective

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Payers

Regulatory

agency

Adopt alternate models like HTA and

trade margin rationalization to

increase affordability of devices

Usher reforms in the

insurance sector for

better health insurance

coverage and establish

systems to rationally

decide reimbursement

price

Build medical infrastructure closer to

the patient base to enable universal,

affordable, quality medical access

Culture of preventive

healthcare through greater

spending on healthcare,

especially primary careIncrease availability of trained talent

to better diagnose disease and

provide necessary treatment

Based on overall analysis and discussions, following key areas have been identified for ensuring

effective access to medical devices

Recommendations

Procure medical

devices under public

health schemes to

increase accessibility

& improve affordability

Establish a holistic ecosystem

for medical device industry

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25 Medical devices in India- an agenda to effective

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1

The following initiatives could be focused for developing infrastructure beyond metros and tier-1 cities to

radically improve accessibility to medical devices across India

a) Promote public-private partnership (PPP) in the healthcare sector to address infrastructure concerns

through combined efforts of public, private and development organizations. Few examples of such

PPP’s in India:

Government is already taking steps in this direction. NITI Aayog has constituted a committee to discuss

options for PPP for services (prevention, diagnosis and treatment) related to select Non-Communicable

Diseases (namely Oncology, Cardiology and Pulmonology) in district hospitals

b) Harness technology to increase reach of existing infrastructure in low tier towns through telemedicine

and telehealth

State PPP example Benefit

West Bengal18

Installation of diagnostic equipment’s

like CT scan, MRI, X-ray etc. by private

providers in public hospital premises on

contract basis

• Increased access to such services

• Reduced cost for these services

Maharashtra19

GE healthcare entered into partnership

with Maharashtra Government to open

advanced diagnostic facilities at 22

Government district hospitals

• 24/7 in-house diagnostic facilities at

Government fixed rates

• Free diagnostic services to BPL

patients

Karnataka20

The Rajiv Gandhi Super-specialty

Hospital in Raichur, Karnataka is a joint

venture of the Government of Karnataka

and the Apollo hospitals Group

• Super-specialty health care at low

cost to BPL people (infrastructure

support by Govt. and operational

support by Apollo)

Build medical infrastructure closer to the patient base to enable universal, affordable, quality medical access

Organization Details

Narayana

Hrudayalaya (NH)

NH along with ISRO and Govt. of Karnataka initiated an experimental tele-

medicine project called ‘Karnataka Integrated Tele-medicine and Tele-health

Project’ (KITTH), which is an on-line health-care initiatives in Karnataka. With

connections by satellite, this project functions in the Coronary Care Units of

selected district hospitals that are linked with NH. Each CCU is connected to

the main hospital to facilitate investigation by specialists after ordinary doctors

have examined patients. This improves access to specialty care and reduces

both time and cost for rural and semi-urban patients

Celes Care-

Healthcare for

women by women

Celes Care aims to provide women of all ages with state of the art, tech-

enabled telehealth services delivered 24/7 through medical professionals, who

are trained on international best practices. Women can use their mobile

phones to connect with trained female physician in less than a minute. Celes'

empowering, patient-centric approach has already helped over 6000 women

during the company’s pilot phase.

18 http://www.wbhealth.gov.in/notice/eoi_gm1.pdf19 http://ehealth.eletsonline.com/2013/06/ensocare-and-wipro-ge-healthcare-enter-into-a-

public-private-partnership-with-government-of-maharashtra-to-upgrade-district-hospitals/20 http://www.ibef.org/download/PublicPrivatePartnership.pdf

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26 Medical devices in India- an agenda to effective

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Government should focus on procuring medical devices through a centralized procedure/ mechanism in

various public health schemes. This will offer the following advantages:

Help Government meet the increasing demand for medical devices

Enables faster public access to advanced medical devices in relatively short period of time at affordable

prices

Provides incentives to manufacturers, as this guarantees certain volumes to manufacturer

Case study21

Effective and efficient centralized drug procurement system followed by the Tamil

Nadu government

21 http://uhc-india.org/reports/hleg_report_chapter_3.pdf

http://www.searo.who.int/publications/journals/seajph/issues/acros

ssectionalsurveyofthemodelinbiharandtamilnaduindiaforpooledproc

urementofmediciness.pdf

► Improved availability

► Improvised distribution of medicines across dispensaries

► A study shows average availability of drugs in TN was 88% compared to 43% in Bihar

► Proportion of stock-outs in TN was around 17%, with average duration of 105 days, compared to 42% stock-outs with mean duration of 105 days in Bihar

► Low cost of procurement- This system has helped Government save the cost of drugs by about 30%

► Reduced stocking needs- Procures only 240 key drugs, as against 960 done earlier

Drug procurement in

the state was scattered

with every hospital

sourcing drugs on its

own with no standard

process leading to :

- High cost of

procurement

- Low visibility on

inventory

- Wastage

- Low availability

Procure medical devices under public health schemes to increase accessibility and improve affordability

2

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27 Medical devices in India- an agenda to effective

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Increase availability of trained talent to better diagnose disease and provide necessary treatment

3

Supply of healthcare professionals could be increased by the following:

a) Identify areas/ regions with critical shortage of medical professionals and expand supply in medical

education seats accordingly

b) Explore public private partnerships for rapid increase in medical education seats

c) Integration of AYUSH doctors into the fold of modern medicine for primary healthcare delivery in rural

areas through bridge training (80% of the training given to AYUSH doctors is identical to the one

given to MBBS doctors)

d) Invest in technology to accelerate skill development in rural areas at minimal cost

Case study- ICTPH bridge training program for integration of AYUSH into rural healthcare

delivery

Details Partnerships

• Evidence based clinical protocols and guidelines

for primary care delivery in community setting form

the core of this training program

• 81 major and minor ailments included like fever,

URTI, diabetes, hypertension etc.

• Knowledge partner-

University of Pennsylvania

School of Nursing & JIPMER

• Implementation partner-

SughaVazhvu Healthcare

Case study- Maharashtra medical education department planning to choose PPP based model

for new medical colleges in the state

• Convert district hospitals into medical colleges through PPP with parties like trusts, not-

for-profit companies etc.

• Government to get a quota of 25% seats in these medical colleges

• Admission to remaining seats can take place through NEET (national eligibility cum

entrance test)

Type Possible benefits Examples

Virtual training and

learning

Reduces the need for additional medical

infrastructure

Simulated labs

creation of an artificial

environment for education,

assessment, and research

Low cost training, higher learning

opportunities as training done in absence of

patients, no risk as patients not involved,

better learning compared to standard training

Online CMEsKnowledge upgradation of doctors for better

patient care

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28 Medical devices in India- an agenda to effective

healthcare delivery

The Indian healthcare system showcases a strong bias towards curative rather than preventive care. This

reliance on a treatment model is evident from the insufficient number of screening and surveillance

programs marking the undertone of the healthcare delivery model. There is a strong need to change the

focus diametrically and move from treatment model to preventive model.

Initiatives are required across the following:

Prevention Timely diagnosisPrompt treatment &

follow-up

• Increase public spend on

healthcare with a focus on

the following:

Increasing knowledge of

preventable risk factors

Promoting benefits of

healthy living and early

treatment

Exposing dangers

associated with late

diagnosis

• Education on risks

associated with poor

personal hygiene and

sanitation

• Health education on diets

and benefits of physical

activity

• Expand availability of

trained talent through

training of primary health

physicians

• Increase the availability of

screening tools like echo,

external loop recorders

(ELRs), holters, X-ray

machines etc.

• Conduct Government

sponsored mass

screening programs

• Protocols/ Guidelines-

develop guidelines clearly

highlighting treatment

pathway based on disease

symptoms

• Strong referral network-

Develop referral chain with

expansive and networked

primary care

Focus on preventive care would not only facilitate in catching any illness young but also minimize the cost

burden of these diseases along the treatment cycle, therefore strengthening the healthcare system in its

totality.

Culture of preventive healthcare through greater spending on healthcare, especially primary care

4

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29 Medical devices in India- an agenda to effective

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Usher reforms in the insurance sector for better health insurance coverage and establish systems to rationally decide reimbursement price

a) India need to focus on universal health insurance coverage to drive access to medical devices.

Multiple models could exist for universal health coverage depending on the following:

Different approaches used by health systems in emerging markets for universal health coverage:

Parameter Options Considerations for India22

What services

are covered?

• Basic care

• Comprehensive care

• Basic care including services with maximum

population impact

• (Universal coverage for comprehensive care is

difficult in large population countries like India)

How are

services

financed?

• Payroll contribution

• Annual premiums

• Tax payments

• Contribution by

government

India need to follow a mixed approach with the

following:

• Payroll deductions for employed

• Periodic contribution to dedicated health savings

accounts for rest of the population

• Public contribution for disadvantaged/ BPL people

Who provides

care?

• Primarily public

• Primarily private

• Mix of public and

private

• Private sector to lead in care provision while

Government to focus on primary care and under-

served segments

22 Universal health coverage 3- The Lancet, IQVIA

analysis

5

Parameter Ghana Indonesia South Korea

What

services are

covered?

Comprehensive coverage-

preventive, primary,

hospital, and (in some

cases) drug benefits to

entire population

Comprehensive

coverage- preventive,

primary, hospital, and (in

some cases) drug

benefits to entire

population

Comprehensive care including

health check-ups, tests and

diagnosis, treatments,

surgeries, preventive care,

hospitalisation, nursing,

rehabilitation and transportation

How are

services

financed?

Value-added tax,

investment income, formal-

sector payroll contributions,

household premiums

General Government

revenues, contribution

by employers, individual

contribution by high

income groups

General taxes and earmarked

amount of tobacco tax,

mandatory health insurance

contribution by employers and

employee

Who

provides

care?

Mix of public and private Mix of public and private Primarily private providers

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30 Medical devices in India- an agenda to effective

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b) Further, there is a need to rationally decide reimbursement limits for different services to ensure quality

care at affordable prices.

Multiple healthcare reimbursement approaches exist:

Considering the challenges associated with different traditional reimbursement models, there is need for

India to adopt innovative models like comprehensive care payment

Fee for service

(FFS)

Episode of care

payment (ECP)

Full capacitation

Risk Patient over-treatment Patient under-treatment

Fee for service (FFS) Episode of care payment

(EOC)

Full capacitation

Services are unbundled and

paid for separately.

Payments are linked to

specific procedures,

treatments, services and

care settings.

A single price for all of the

services needed by a

patient for an entire

episode of care (e.g., all of

the inpatient and outpatient

care they need after having

a heart attack).

Providers receive a fixed

amount per patient per year

and are responsible for all of

that patient’s medical

needs.

Model

Details

Challenges

Reimbursement

increases with the quantity

of procedures, tests,

admissions and

re‐admissions that occur,

whether or not they

contribute to better patient

outcomes.

Does not control the no. of

episodes during the stay of

patient

With a fixed overall revenue

for a patient,

providers (and payers) may

ration or deny access to

expensive procedures and

services even if the services

can lead to better long‐run

outcomes.

Advantages

Greater flexibility to patients

for seeking the advice and

consultation of a specialist

whenever needed

Reduced incentive to

overuse unnecessary

services within the episode

As provider revenues are

independent of the specific

quantity and types of

treatments performed, it

motivates providers to be

more efficient

This is a middle ground between EOC payment and traditional capitation.

Under this model, a provider would receive a single payment to cover all of

the services their patients need during a specific period of time (such as a

year). However, this payment would be adjusted based on the health of the

patients and other characteristics that affect the level of services needed. A

provider would receive a higher payment if he or she has more patients with

severe rather than mild heart disease

Comprehensive care

payment

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31 Medical devices in India- an agenda to effective

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Fee for service Episode of careComprehensive

care paymentCapitation

Discourages un-

necessary services in an

episode?

No Yes Yes Yes

Pays for all necessary

services in an episode?Yes Yes Yes Yes

Encourages coordination

of multiple providers?No Yes Yes No

Encourages providing

high quality services?No

Yes

for services

affecting

outcomes that

occur within the

episode

Yes

for services

affecting

outcomes that

occur within the

payment period

No

Avoids penalty of taking

sicker patients?Yes Yes Yes No

Discourage unnecessary

episodes?No No Yes No

Comparison of various payment systems:

Creating efficient comprehensive care payment would require the following:

• Defining the medical condition and the covered cycle of care

• Defining and measuring the outcomes that matter

• Risk stratification approach based on patients risk factors and co-morbidities

• Estimating provider costs over the cycle of care

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32 Medical devices in India- an agenda to effective

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Adopt alternate models to increase affordability of medical devices

6

In order to improve affordability, Government should focus on adopting alternate pricing models factoring

in clinical performance/ innovation, safety and effectiveness of the device. Government should not restrict

to price control as the sole ‘access augmenting’ mechanism, as this may hamper the growth of medical

device industry and restrict the access to innovative medical devices.

To achieve the twin objectives of encouraging innovation and increasing access to medical devices,

Government may resort to following two strategies:

a. Short term- Trade margin rationalization

b. Long term- Building competency in health technology assessment (HTA)

Trade margin rationalization

There is a need for the Government to focus on trade margin rationalization i.e. imposing a cap on the

margins across the value chain, rather than capping ceiling price of devices. Unlike price caps which dis-

incentivize innovation, fixing trade margins would restrict how much a product’s price can be raised from

the import or manufacturing cost, but innovation would still be rewarded.

The Report of the Committee in High Trade Margins in the sales of Drugs released in March 2016 by

Department of Pharmaceuticals has identified that most of the margins are earned by trade and therefore,

in order to make drugs and devices affordable, recommended to cap margins from “Price to Trade till

MRP” in the range of 35-50%. The report is appreciated by Medical Devices industry as a solution to

make products affordable.

Further, trade margin rationalization would be better than "un-nuanced" caps on device ceiling prices

because it would prevent "unintended consequences" like distributors becoming disinterested in providing

these technologies to tier-II and III towns.

The issue of rationalization of trade margins in medical device sector is already under consideration by

the Department of Pharmaceuticals and they have prepared a report on the same. This could be an

immediate solution for enhancing access, with industry support.

Building competency in health technology assessment (HTA)

Government should develop a robust medical technology assessment program which considers factors

like evidence of safety, efficacy, patient reported outcomes, real world effectiveness, cost and cost

effectiveness in evaluating a medical device to arrive at the right product at rational prices for anticipated

scenarios

HTA will offer the following advantages:

• Support innovations in the medical device industry

• Support Government to facilitate decisions in technology adoption

• Improved patient access to new medical devices

• Performance/ effectiveness based pricing resulting in higher value for money

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Establish a holistic ecosystem for medical device industry

7

To attract world’s top medtech players to establish their research and development (R&D) operations in

the country and to establish a firm footing in the global market, Government of India needs to adopt a

robust policy and regulatory framework.

India can replicate some of the models being adopted by other nations that have succeeded in attracting

leading medical players.

• Government of India can provide financial incentives in form of extended tax holidays or weighted tax

reduction for R&D investments.

• Boost local demand for medical devices by stepping up public healthcare spending which in-turn could

catalyze investments in this sector

Further, Government should focus on creating an enabling regulatory landscape by creating a separate

legislation system for medical devices. While, Medical Devices Rules, 2017 is a welcome step towards

regulating the medical devices sector, the setting up separate notified body and distinct legislation system

for devices with a focus on the following could further boost growth of the industry.

• Grant product approvals

• Instituting quality standards

• Setting up monitoring mechanisms for devices

• Expedite patent approval process for medical devices

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34 Medical devices in India- an agenda to effective

healthcare delivery

Based on the current state of healthcare delivery in India, it is understood that there is still a long way to go

in terms of making advanced medical devices available to the Indian patient. Due to inadequate healthcare

infrastructure and absence of trained manpower, availability becomes a major concern in increasing

access to medical devices.

Huge investments will be required to upgrade the existing infrastructure, in order to improve accessibility

to medical devices. This would need greater involvement of the private sector and government should

seek ways to collaborate with the private sector who could provide the required expertise and support.

An integrated approach that takes into consideration the interest of all key stakeholders is imperative. It is

important to seek a win-win solution rather than approaches that are heavily loaded against a particular

stakeholder.

Through this paper we hope to initiate a meaningful dialogue that helps design sustainable solutions

focusing on effective healthcare delivery.

Conclusion

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35 Medical devices in India- an agenda to effective

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"Healthcare in India has progressed tremendously in the last few years. To continue this

progress and support India's vision to be at the forefront of medical technology, the

entire healthcare ecosystem, including regulators, researchers, hospitals, government

bodies and industry need to work together on a framework that supports innovation as

well as better access to technologies for patients. Access to healthcare innovation

extends well beyond affordability and pricing, and will require many people working

together toward policy changes that address the entire landscape to support physicians

and their patients."

Spokesperson, Abbott

“The Medtech sector in India is fairly small compared to other leading economies of the

world. Comparatively, the per capita consumption of medical devices remains low at

US$ 3. With the rising incidence of CVDs, NCDs and chronic diseases, the need to

develop this sector to provide innovative medical solutions to tackle the healthcare

burden in the country, is greater than ever.

It is essential to drive market demand and growth by enabling investments,

infrastructure development, skill building, training, and improving patient access—a

pivotal role that both the Government and private sector must play.

Thoughtful healthcare policies, favorable to both patients and the industry, that

systematically address reimbursement, health assurance and pricing will support this

growth and help India achieve its vision of Universal Health Coverage.

Medical Devices is a technology driven sector, and continued innovation is critical to

sustaining long-term solutions for unmet healthcare needs. An environment with a focus

on R&D and innovation, and recognition of the diverse range of technologies will boost

industry confidence and investments, ensuring continued access to newer technologies

and therapies from around the globe.

India’s Medtech sector requires a unique set of measures that draw on the synergies of

the Government, private sector, academia and patient groups, to establish collaborative

approaches in finding affordable and accessible healthcare solutions.”

Spokesperson, Boston Scientific

Industry views

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36 Medical devices in India- an agenda to effective

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“We applaud the government’s call for affordable healthcare to all and the industry is

keen to constructively partner with them in achieving this goal. While we gradually

progress towards the government’s long-term goal of universal healthcare for all, it will

be the key to foster a supportive regulatory environment which provide the right kind of

incentives and market attractiveness for all stakeholders.

We recommend an evidence-based action plan that can be adopted to meet the

immediate and long-term needs of almost 1.27 billion people in India. For this, we need

to consider alternatives to price control such as trade margin rationalization and more

scientific approaches that facilitate differential pricing for innovative medical

technologies. Capping the trade margin to 50 %, as per the DOP report will bring in a

rationalized margin to various segments of medical devices, thereby, bringing down the

cost of the devices, as well as more transparency in pricing.

Such a mechanism will invalidate the need for measures such as price control as fair

margins are provided to all stake holders, also enabling companies to bring in

differential pricing according to newer technologies. This will be symbiotic to the

healthcare ecosystem, and enable an improved access to an array of medical

innovations and solutions in India.”

Spokesperson, Terumo

“Medical devices industry in India is still at a nascent stage and has an opportunity to

grow exponentially with the right kind of policy framework. Improvements in hospital

capacity, increasing number of implanting physicians, bringing awareness on disease

diagnosis and most importantly raising public awareness will give the industry, the

much needed boost to harness the immense opportunities on offer.

The vitality of the medical device industry is reflected in its focus on Research and

Development. Innovations in medical technology improves peoples’ lives, and brings

the benefits of treatment to individuals whose conditions may previously have been

difficult or impossible to treat. With product lifecycles in the sector averaging only 18

months between improvements, the drive to advance and innovate within the industry is

continuous.

A holistic and coordinated approach towards addressing all challenges simultaneously

and putting thrust on innovations will help the medical devices industry inch closer to

the goal of universal healthcare and strong patient outcomes.”

Spokesperson, Medtronic

Industry views

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37 Medical devices in India- an agenda to effective

healthcare delivery

About IQVIA

IQVIA is a leading global provider of information, innovative technology solutions and contract research services

focused on using data and science to help healthcare clients find better solutions for their patients. Formed through

the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in

healthcare information, technology, analytics and human ingenuity to drive healthcare forward. IQVIA enables

companies to rethink approaches to clinical development and commercialization, innovate with confidence as well

as accelerate meaningful healthcare outcomes.

IQVIA has approximately 55,000 employees in more than 100 countries, all committed to making the potential of

human data science a reality. IQVIA’s approach to human data science is powered by the IQVIA CORE™, driving

unique actionable insights at the intersection of big data, transformative technology and analytics with extensive

domain expertise. IQVIA’s insights and execution capabilities help biotech, medical device, and pharmaceutical

companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a

deeper understanding of diseases, human behaviors and scientific advances, in an effort to advance their path

toward cures. To learn more, visit www.IQVIA.com

About AdvaMed

The Advanced Medical Technology Association (AdvaMed), is a trade association that leads the effort to advance

medical technology in order to achieve healthier lives and healthier economies around the world. AdvaMed’s

membership has reached nearly 300 members and more than 80 employees with a global presence in countries

including Europe, India, China, Brazil, and Japan. AdvaMed's member companies range from the largest to the

smallest medical technology innovators and companies. The Association acts as the common voice for companies

producing medical devices, diagnostic products and health information systems.

AdvaMed advocates on a global basis for the highest ethical standards, timely patient access to safe and effective

products, and economic policies that reward value creation. Additional information is available at

https://www.AdvaMed.org/